Predicting efficacy of neuromodulation in epilepsy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23690

Enrollment

Registered

2020-07-27

Start date

2020-07-27

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Interventions

Not applicable.

Eligibility

Inclusion criteria

Inclusion criteria: • Adult (>=18 year) patients with medically refractory epilepsy, who are candidates for VNS. • Known with a focal epilepsy with a temporal/frontotemporal seizure-onset zone (as corroborated by EEG or magnetic resonance imaging [MRI]) or a generalized epilepsy. • A self-reported seizure frequency of at least one seizure per month.

Exclusion criteria

Exclusion criteria: • Prior brain surgery. • Cognitive impairments that causes the patient to be unable to onderstand the research purpose and give informed consent. • Exclusion criteria (for safety issues) to ondergo an MRI scan. • Planned or expected MRI scan during the period where the subcutaneous electrode is implanted.

Design outcomes

Primary

Measure	Time frame
• The primary goal of the pilot study is to test the feasibility and patients' satisfaction of the subcutaneous electrode. • If successful, the study will be expanded to a larger cohort. The primary objective of this larger study is to predict success of VNS in patients with epilepsy using pre-operative features from ultra long-term EEG recordings, resting-state 64-channel EEG and MRI. We will initially aim to predict responders (>50% seizure reduction); this binarized response will be complemented by assessing the likelihood of seizure reduction on a continuous scale.	—

Measure

Time frame

• The primary goal of the pilot study is to test the feasibility and patients' satisfaction of the subcutaneous electrode. • If successful, the study will be expanded to a larger cohort. The primary objective of this larger study is to predict success of VNS in patients with epilepsy using pre-operative features from ultra long-term EEG recordings, resting-state 64-channel EEG and MRI. We will initially aim to predict responders (>50% seizure reduction); this binarized response will be complemented by assessing the likelihood of seizure reduction on a continuous scale.

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Secondary

Measure	Time frame
• To evaluate the correspondence between seizures reported by the patients (using diaries) and the seizures recorded by the subcutaneous electrode. • To study differences in network characteristics derived from 64-channel EEG, and MRI before and after VNS. • To evaluate the effect of VNS on psychologica) well-being including quality of life, anxiety and depression. • To evaluate the effect of VNS on sleep quality (total sleep duration, time to first REM, total time in deep sleep measured with the subcutaneous EEG recording).	—

Measure

Time frame

• To evaluate the correspondence between seizures reported by the patients (using diaries) and the seizures recorded by the subcutaneous electrode. • To study differences in network characteristics derived from 64-channel EEG, and MRI before and after VNS. • To evaluate the effect of VNS on psychologica) well-being including quality of life, anxiety and depression. • To evaluate the effect of VNS on sleep quality (total sleep duration, time to first REM, total time in deep sleep measured with the subcutaneous EEG recording).

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Contacts

Public ContactRosalie Visser

Medisch Spectrum Twente

Rosalie.Visser@mst.nl0534872840

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)